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We studied baseline magnetic resonance images of 155 patients with intermittent neurogenic claudication and lumbar spinal stenosis (LSS). Magnetic resonance imaging (MRI) and patient data were gathered from participants of a randomized trial.It is believed that the narrowness of the lumbar spinal canal correlates to the severity of complaints and that it may be a good predictor of clinical outcome if treated. However, this hypothesis has never been (prospectively) tested.MRI is an important tool to confirm the diagnosis of LSS as a cause for intermittent neurogenic claudication.Three raters were asked to evaluate the magnetic resonance images (Schizas scale). Symptom severities at baseline and 1-year follow-up were quantified. The radiological scores were correlated with clinical baseline and outcome scores to assess diagnostic and prognostic value of MRI findings at baseline.There was good agreement on the clinically relevant level of LSS (kappa range 0.57-0.64). MRI assessment of grading of compression (kappa 0.33-0.46) did not correlate with baseline MRDQ nor with outcome based on postoperative change in MRDQ (P = 0.61). However, both absence of epidural fat and presence of tortuous caudal nerves on magnetic resonance images (kappa 0.53-0.72 and 0.67-0.70) in patients with LSS were relatively good predictors for satisfactory recovery after surgery (P = 0.03 and P 0.01).The grading of compression on the preoperative MRI is neither ambiguous nor correlating to severity of clinical condition. It does, furthermore, not have the ability to predict the outcome after 1 year if surgically treated.2.

Interspinous process devices (IPDs) are implanted to treat patients with intermittent neurogenic claudication (INC) based on lumbar spinal stenosis. It is hypothesized that patients with lumbar spinal stenosis treated with IPD have a faster short-term recovery, an equal outcome after 2 years and less back pain compared with bony decompression. A randomized design with variable block sizes was used, with allocations stratified according to center. Allocations were stored in prepared opaque, coded and sealed envelopes, and patients and research nurses were blind throughout the follow-up. Five neurosurgical centers (including one academic and four secondary level care centers) included participants. 211 participants were referred to the Leiden-The Hague Spine Prognostic Study Group. 159 participants with INC based on lumbar spinal stenosis at one or two levels with an indication for surgery were randomized into two groups. Patients and research nurses were blinded for the allocated treatment throughout the study period. 80 participants received an IPD and 79 participants underwent spinal bony decompression. The primary outcome at long-term (2-year) follow-up was the score for the Zurich Claudication Questionnaire. Repeated measurement analyses were applied to compare outcomes over time. At two years, the success rate according to the Zurich Claudication Questionnaire for the IPD group [69 % (95 % CI 57-78 %)] did not show a significant difference compared with standard bony decompression [60 % (95 % CI 48-71 %) p value 0.2]. Reoperations, because of absence of recovery, were indicated and performed in 23 cases (33 %) of the IPD group versus 6 (8 %) patients of the bony decompression group (p < 0.01). Furthermore, long-term VAS back pain was significantly higher [36 mm on a 100 mm scale (95 % CI 24-48)] in the IPD group compared to the bony decompression group [28 mm (95 % CI 23-34) p value 0.04]. This double-blinded study could not confirm the advantage of IPD without bony decompression over conventional 'simple' decompression, two years after surgery. Moreover, in the IPD treatment arm, the reoperation rate was higher and back pain was even slightly more intense compared to the decompression treatment arm.

Objective To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis. Design Randomized controlled trial. Setting Five neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands. Participants 203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized. Interventions 80 participants received an interspinous process device and 79 participants underwent spinal bony decompression. Main outcome measures The primary outcome at short term (eight weeks) and long term (one year) follow-up was the Zurich Claudication Questionnaire score. Repeated measurements were made to compare outcomes over time. Results At eight weeks, the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for standard bony decompression (72%, 60% to 81%). No differences in disability (Zurich Claudication Questionnaire; P=0.44) or other outcomes were observed between groups during the first year. The repeat surgery rate in the interspinous implant group was substantially higher (n=21; 29%) than that in the conventional group (n=6; 8%) in the early post-surgical period (P

OBJECTIVE: This study describes the 5 years' results of the Sciatica trial focused on pain, disability, (un)satisfactory recovery and predictors for unsatisfactory recovery.DESIGN: A randomised controlled trial.SETTING: Nine Dutch hospitals.PARTICIPANTS: Five years' follow-up data from 231 of 283 patients (82%) were collected.INTERVENTION: Early surgery or an intended 6 months of conservative treatment.MAIN OUTCOME MEASURES: Scores from Roland disability questionnaire, visual analogue scale (VAS) for leg and back pain and a Likert self-rating scale of global perceived recovery were analysed.RESULTS: There were no significant differences between groups on the 5 years' primary outcome scores. Despite at least 6 months of conservative treatment 46% of the conservatively allocated patients were treated surgically because of severe leg pain and disability. Forty-nine (21%) patients had an unsatisfactory recovery at 5 years and the recovery pattern showed that there was a variable group of 66 patients (31%) with at least one unsatisfactory outcome at 1, 2 or 5 years of follow-up. Multivariate logistic regression showed that age (>40; OR 2.42 (95% CI 1.16 to 5.02)), severity of leg pain (VAS >70; OR 3.32 (95% CI 1.69 to 6.54)) and the Mc Gill affective score (score >3; OR 6.23 (95% CI 2.23 to 17.38)) were the only significant predictors for an unsatisfactory outcome at 5 years.CONCLUSIONS: In the long term, 8% of the patients with sciatica never showed any recovery and in at least 23%, sciatica appears to result in ongoing complaints, which fluctuate over time, irrespective of treatment. Prolonged conservative care might give patients a fair chance for pain and disability to resolve without surgery, but with the risk to receive delayed surgery after prolonged suffering of sciatica. Age above 40 years, severe leg pain at baseline and a higher affective Mc Gill pain score were predictors for unsatisfactory recovery. Trial Registry ISRCT No 26872154.

This thesis is about effectiveness of surgical interventions in the spine and the value of different methodologies for providing a valid answer. In the first part five systematic reviews were performed. One reviewed cervical degenerative disc disease comparing the different anterior fusion techniques. Two were performed on lumbar disc herniation comparing conservative interventions with surgical and comparing the several surgical techniques. One was on lumbar degenerative disc disease and evaluated disc replacement. The fifth evaluated interventions for low grade lumbar isthmic spondylolisthesis. In the second part systematic reviews were searched, selected and appraised in two meta-epidemiological studies. Spinal research suffers from specific problems with regard to randomization and related to that, blinding and allocation concealment. These are factors that have in other medical fields been shown to introduce biased results. Our studies showed that observational studies in spinal surgery research do not result in an overestimation of the treatment effect in contrast to other medical disciplines. Finally, the experience gained from these studies has resulted in several opinion papers that aim to guide the scientific field in using the most appropriate methods in spine surgery research.